Randomized Clinical Trial Of A Family
blog.pharmacydiscountmeds.com - A prospective randomized trial by Dr. Northouse and associates published in the December issue of Cancer suggests that prostate cancer (CaP) patients and their spouses benefit from family intervention counseling. Interestingly, spouses benefited more.
Both CaP and treatment related side effects can have a negative effect on patients and their spouses. The objective of the study was to assess whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress (general and prostate-specific), and QoL in patients and their spouses during 3 phases of CaP; newly diagnosed, biochemical recurrence and advanced. The phases of CaP and risk for distress were evaluated as to whether they created a differential effect of the intervention on patient or spouse outcomes. The patient and spousal assessments were performed at 4, 8, and 12 months after enrollment. Masters-prepared nurses delivered the intervention and data collection nurses were blinded to the group assignment (intervention or control). The intervention arm encouraged families to work as a team, communicate openly about the illness, and provide one another with support. The control arm was standard of care.
Established instruments measured all study variables. This included detailed questionnaires for QoL, appraisals of illness/caregiving, coping strategies, general symptom distress, and the risk of developing future emotional distress. A total of 263 couples were enrolled and completed baseline evaluations. At 4 and 12 months 235 (90%) and 218 (83%) dyads completed the follow-up assessments, respectively. There were no differences between the intervention and control arms regarding follow-up participation. Average patient age was 63 years and average spouse age was 59 years. The vast majority (84%) were Caucasian. The enrollment consisted of 65% in the newly diagnosed category (60% had surgery and 40% radiotherapy), 14% with biochemical recurrence, and 21% with advanced disease. It was noted that 25% of spouses had health problems.
There were no differences between the arms regarding QoL variables. The intervention and control groups did not differ on appraisal variables but patients in the intervention group did report less uncertainty about their illness than controls at 4 months. Intervention patients reported more communication about the illness with their spouses than control men at 4 months. There were no differences between groups on general or prostate-specific symptom distress.
Intervention spouses reported better physical QoL than control spouses at 8 and 12 months. They also had better mental QoL scores. Intervention spouses had less negative appraisal of caregiving, less uncertainty about the illness, less hopelessness, higher self-efficacy about ways to manage the illness, and less general symptom distress. The phase of illness and risk for distress did not seem to moderate the effectiveness of the intervention.
